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United States Patent |
5,772,631
|
Lepor
|
June 30, 1998
|
Procedure for alleviating arterial obstruction
Abstract
A medical device and method for performing percutaneous transluminal
coronary angioplasty (PTCA) and intra-aortic balloon (IAB)
counterpropulsion, the device including: a guide catheter insertable into
a coronary artery, the guide catheter having an outer surface; an IAB
mounted on the outer surface of said catheter; and a PTCA catheter
insertable into a coronary artery through the guide catheter, the PTCA
catheter including an angioplasty balloon.
Inventors:
|
Lepor; Norman E. (9770 Apricot La., Beverly Hills, CA 90210)
|
Appl. No.:
|
430219 |
Filed:
|
April 28, 1995 |
Current U.S. Class: |
604/96.01; 600/18; 606/194 |
Intern'l Class: |
A61M 029/00 |
Field of Search: |
604/22,96,101
600/16-18
606/192,194,195
|
References Cited
U.S. Patent Documents
4531936 | Jul., 1985 | Gordon.
| |
4569332 | Feb., 1986 | Schiff et al. | 600/18.
|
4697574 | Oct., 1987 | Karcher et al. | 600/18.
|
4733652 | Mar., 1988 | Kantrowitz et al. | 600/18.
|
4741328 | May., 1988 | Gabbay.
| |
4911163 | Mar., 1990 | Fina | 606/192.
|
4990139 | Feb., 1991 | Jang | 606/192.
|
5158540 | Oct., 1992 | Wijay et al.
| |
5176619 | Jan., 1993 | Segalowitz | 600/18.
|
5180367 | Jan., 1993 | Kontos et al. | 604/194.
|
5195942 | Mar., 1993 | Weil et al. | 604/194.
|
5226889 | Jul., 1993 | Sheiban | 606/194.
|
5308319 | May., 1994 | Ide et al.
| |
5334142 | Aug., 1994 | Paradis.
| |
5342297 | Aug., 1994 | Jang.
| |
5409444 | Apr., 1995 | Kensey et al.
| |
5449342 | Sep., 1995 | Hirose et al. | 600/16.
|
Primary Examiner: Bockelman; Mark
Attorney, Agent or Firm: Loeb & Loeb LLP, Ram; Michael J.
Claims
What is claimed is:
1. A procedure for performing percutaneous transluminal coronary
angioplasty (PTCA) and intra-aortic balloon (IAB) counterpropulsion with a
medical device, the medical device being composed of: a guide catheter
insertable into a coronary artery, said guide catheter having an outer
surface and a lumen; an IAB mounted on said outer surface of said
catheter; and a PTCA catheter insertable into a coronary artery through
said guide catheter lumen, said PTCA catheter including an angioplasty
balloon, said procedure comprising:
inserting the guide catheter into the coronary artery to position the IAB
into a descending aorta of the patient;
inserting the PTCA catheter through the guide catheter lumen to bring the
angioplasty balloon to the site of an obstruction in the coronary artery;
inflating the angioplasty balloon to effect radial outward displacement of
the obstruction; and
responding to hemodynamic instability experienced by the patient by
inflating and deflating the IAB in synchronism with the rhythm of the
patient's heart.
2. The procedure according to claim 1 wherein said step of inserting the
guide catheter into the coronary artery is performed by inserting the
guide catheter via a vascular sheath.
Description
BACKGROUND OF THE INVENTION
The present invention relates to medical devices and procedures for
alleviating arterial obstructions.
When an obstruction, e.g. a stenosis, occurs in a coronary artery, a common
treatment for alleviating the obstruction is known as percutaneous
transluminal coronary angioplasty (PTCA). This involves insertion of a
balloon into the coronary artery to the location of the obstruction
followed by inflation of the balloon to stretch the artery, compress the
obstruction and create a clear passage for the flow of blood. After the
balloon is deflated and removed, the passage generally remains open, at
least for a period of time.
Performance of a PTCA conventionally involves a procedure composed of the
following steps, performed in the order described:
a hollow core needle is introduced through the patient's skin into the
femoral artery;
a first guide wire is inserted into the artery through the needle;
a vascular sheath, which is essentially a hollow plastic tube, is then
inserted through the hollow core needle, over the guide wire;
after the removal of the guide wire and needle, a hollow plastic coronary
guiding catheter with a second guide wire is then introduced through the
sheath and, under X-ray guidance, is placed into the coronary artery. The
plastic catheter contains a lumen with a diameter sufficient to receive a
small PTCA balloon;
the second guide wire is then removed and a special coronary artery guide
wire is inserted under X-ray guidance to the site of the obstruction and
then eased past the obstruction towards the end of the artery. A PTCA
catheter carrying the PTCA balloon is then placed around the coronary
artery guide wire and advanced through the lumen of the guiding catheter
to the site of the blockage, while dye is injected into the artery through
that lumen to facilitate visualization of the vascular structure to be
treated and to assist placement of the balloon in the proper position; and
the PTCA balloon is then placed at the site of the obstruction and is
inflated in order to reestablish a blood flow passage through the artery.
Following balloon deflation it is removed with the coronary guide wire.
The success and complication rates of the above procedure vary over a wide
range depending, inter alia, on the characteristics of the stenosis and
the condition of the patient. Risks associated with the procedure include
death, myocardial infarction and the need for emergency bypass surgery.
There are occasions when it is difficult to open an artery, or in which
the condition of the artery actually worsens and the artery closes during
the procedure, resulting in chest pain, shock, or even death. When such a
condition, which is evidenced by chest pain, EKG changes and/or
hemodynamic instability in the patient, occurs, efforts must be made to
stabilize the patient with a minimum delay.
A common technique for dealing with these complications is to place an
intra-aortic balloon (IAB) into the aorta, using the other femoral artery
from that employed for inserting the PTCA balloon. Placement of an IAB is
effected by a technique similar to that described above for inserting a
PTCA guide catheter.
An IAB device includes a long catheter extending within the descending
aorta and having, on its outer surface, a plastic balloon that can be
inflated and deflated in synchronism with the heart rhythm to increase the
pressure in the aorta during diastole, and thereby to enhance heart
function.
Under the best of circumstances, and even when the operating personnel have
sufficient experience, insertion of the IAB takes a certain amount of
time, which can be critical in dealing with the emergency condition.
Moreover, there will be situations in which the introduction of the IAB
will be rendered more difficult by the condition which it is to treat. For
example, when a patient develops shock, it sometimes becomes almost
impossible to locate the other femoral artery, in which case insertion of
the IAB becomes impossible. In addition, when the operator is inserting
the IAB, he is not able to, at the same time, continue attempting to deal
with the closed artery in order to restore blood circulation. Thus, in
various circumstances where an IAB may be helpful, it may be decided that
any attempt to insert that device will create more risks than it
alleviates.
An attempt to place the IAB in the same femoral artery as that employed for
insertion of the PTCA catheter precludes the physician operator from
proceeding with attempts at opening the blocked coronary artery, exposing
the patient to a higher risk of myocardial infarction and death.
There are also occasions when patients present to the hospital with a
myocardial infarction and are hemodynamically unstable with very low blood
pressure, cardiogenic shock. A device according to the invention can be
placed either in the emergency or catheterization laboratory to provide
intra-aortic balloon counterpulsation as a supportive measure while
simultaneously allowing for more timely emergency balloon angioplasty as
the guiding catheter is already in place ready for the PTCA balloon.
SUMMARY OF THE INVENTION
It is a primary object of the present invention to provide a solution to
the above-described problems.
Another object of the invention is to make an IAB immediately available for
emergency use during PTCA.
A further object of the invention is to provide apparatus which makes an
IAB immediately available at the location needed during a PTCA procedure.
The above and other objects are achieved, according to the present
invention, by a medical device for performing percutaneous transluminal
coronary angioplasty (PTCA) and intra-aortic balloon (IAB)
counterpropulsion, comprising: a guide catheter insertable into a coronary
artery, the guide catheter having an outer surface; an IAB mounted on the
outer surface of said catheter; and a PTCA catheter insertable into a
coronary artery through the guide catheter, the PTCA catheter including an
angioplasty balloon.
BRIEF DESCRIPTION OF THE DRAWINGS
The sole Figure is a cross-sectional detail view of the distal end of a
preferred embodiment of a medical device according to the present
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
A device according to the invention, as illustrated in the Figure, includes
a guide catheter 2 having the same shape, structure and dimensions as
coronary guide catheters which are currently in use, i.e. catheter 2 is
provided with a lumen. Guide catheter 2 is provided, in a region spaced a
short distance from its distal end 4, with an annular IAB 6 of
conventional construction. Prior to insertion of the medical device into
an artery, IAB 6 is wrapped tightly around catheter 2 so as to not
interfere with catheter insertion. When needed after insertion, IAB 6 will
be inflated by helium gas supplied via a tube or lumen, in the proximal
descending aorta in the same manner as that currently employed for IABs.
IAB 6 can be connected, via an inflation tube 8, to a conventional console
of the type currently in use for inflation with helium gas and deflation,
inflation and deflation being timed to the cardiac cycle. Helium gas could
be delivered and removed by any conventional technique. When IAB 6 is no
longer needed, it can be deflated, and catheter 2 can be removed through
the vascular sheath (not shown).
The device according to the invention further includes a PTCA catheter 12
which is dimensioned to be insertable through catheter 2. Catheter 12 has
a distal end 14 and is provided, near distal end 14, with an angioplasty
balloon 18. Catheter 12 is formed to have a balloon inflation lumen 20
which communicates with the interior of balloon 18 and a further lumen 24
which extends fully to distal end 14. The coronary guide wire extends
through lumen 24 into the distal aspect of the instrumented coronary
artery.
Catheter 12 is utilized in a conventional manner to perform balloon
angioplasty procedures. A considerable benefit offered by the present
invention is that catheter 2, when it acts as a guide catheter for PTCA
catheter 12, is readily available to function as an IAB, if a medical need
for that procedure should arise. Thus, without any significant addition of
elements into an artery for angioplasty purposes, the invention makes
available an IAB which is in position for immediate use.
A device according to the present invention would be utilized in
essentially the manner described earlier herein for conventional PTCA
procedures. The differences are that, in place of the hollow plastic
catheter mentioned above, guide catheter 2 according to the invention
would be inserted to position IAB 6 at an appropriate location in the
descending aorta.
A medical device according to the invention would be connected to
conventional systems which are located outside of the patient's body and
which deliver inflation gases in a controlled manner to IAB 6, via
inflation tube 8, and inflation fluids to balloon 18, via inflation lumen
20. Because the systems used for this purpose are conventional and would
be connected to tube 8 and lumen 20 in a conventional manner, those
systems and their connections are not illustrated herein.
While particular embodiments of the present invention have been shown and
described, it will be obvious to those skilled in the art that changes and
modifications may be made without departing from this invention in its
broader aspects and, therefore, the aim in the appended claims is to cover
all such changes and modifications as fall within the true spirit and
scope of this invention.
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